Use of Oculometric Measures in the Differential Diagnosis of Typical and Atypical Parkinsonian Conditions: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- NeuraLight
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change of saccadic latency between subgroups
Study Overview
Brief Summary
This is an observational longitudinal study in 4 cohorts of patients with Parkinsonian syndromes, who are visiting the Movement Disorders outpatient clinics.
The aim of the study is to assess the difference of oculometric measures in different neurodegenerative brain conditions and their accuracy over time, and as compared to clinical diagnosis, in order to find a change over time, difference between subgroups and correlations with accepted clinical endpoints in subjects who meet the inclusion criteria and who provide a signed Informed Consent.
Detailed Description
As a part of the study, about 40 subjects will undergo a neurological evaluation including motor and cognitive assessments and a NeuraLight session including oculometric measurements and eye-tracking recordings using a novel software-based platform and an eye-tracking system (Tobii, CE-marked class B approved device). Test duration will be approx. 20 minutes. The oculometric evaluation will occur for at least 50% of the cohort 3 times (at baseline, at 6-months and at 12-month follow-up), and all subjects will be recruited over a period of 9 months. All assessments will be performed during a clinic visit unless authorized to be conducted remotely.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women, age between 40 and 80 years
- •<5 years since disease diagnosis
- •Normal or corrected vision
- •MOCA score ≥ 20
- •Ability to follow instructions
- •Willing and able to sign an informed consent form Specific
- •PD cohort: Ages 50-80, Hoehn & Yahr scale 1-3
- •PSP cohort: diagnosed according to actual diagnostic criteria from Höglinger GU et al,
- •MSA cohort: diagnosed according to actual diagnostic criteria from Wenning et al, 2022.
Exclusion Criteria
- Not provided
Arms & Interventions
MSA patients
Patients diagnosed with MSA, according to actual diagnostic criteria from Wenning et al, 2022.
Intervention: NeuraLight MSA (Other)
PSP patients
Patients diagnosed with PSP, according to actual diagnostic criteria from Höglinger GU et al, 2017.
Intervention: NeuraLight PSP (Other)
Parkinson patients
Patients diagnosed with Parkinson's disease, ages 50-80, Hoehn & Yahr scale 1-3
Intervention: NeuraLight PD (Other)
Healthy
Healthy subjects with no neurological diseases or cognition deficits
Intervention: NeuraLight (Other)
Outcomes
Primary Outcomes
Change of saccadic latency between subgroups
Time Frame: 12 months
A difference between saccadic latency among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05)
Change of antisaccadic error rate between subgroups
Time Frame: 12 months
A difference between antisaccadic error rate (%) among the cohorts, enabling a categorization of different patients in study cohorts (p\<0.05)
Change of saccadic latency over time as evaluated during visits
Time Frame: 12 months
Difference between saccadic latency (ms) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Change of antisaccadic error rate over time as evaluated during visits
Time Frame: 12 months
Difference between antisaccadic error rate (%) as quantified during each visit by the NeuraLight test measured using a statistical comparison of values (e.g. t-test, ANOVA), p\>0.05) over time during study period
Correlation between MDS-UPDRS score and its parts with saccadic latency
Time Frame: 12 months
The correlation between the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS, scored 0-to a maximum total of 199, indicating the worst possible disability from PD) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
Correlation between UMSARS score and its parts with saccadic latency
Time Frame: 12 months
The correlation between the Unified Multiple System Atrophy Rating Scale (UMSARS) scored 0-to a maximum total of 48, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
Correlation between PSP-CDS and its parts with saccadic latency
Time Frame: 12 months
The correlation between the Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS) scored 0-to a maximum total of 100, indicating the worst possible disability from MSA) and its parts with saccadic latency (ms) measured using R-Square (high correlation\>0.5, moderate correlation 0.2-0.5, low correlation\<0.2), p\<0.05)
Secondary Outcomes
- Correlation between MoCA score and its parts with anti-saccadic error rates(12 months)
- Correlation between MoCA score and its parts with smooth pursuit(12 months)